Lupin gets USFDA nod for Armodafinil and Doxycycline

New Delhi: Drug firm Lupin today said the company`s US subsidiary has received tentative approvals for its Armodafinil tablets and Doxycycline capsules from the US health regulator.

The company`s US subsidiary, Lupin Pharmaceuticals Inc, has received tentative approvals for its Armodafinil tablets in the strengths of 50 mg, 100 mg, 150 mg, 200 mg and 250 mg.

It has also got nod for Doxycycline capsules in the strength of 40 mg (30 mg immediate-release and 10 mg delayed-release) from the United States Food and Drugs Administration (USFDA), Lupin said.

"The company`s tablets are AB-rated generic equivalent of Cephalon Inc`s Nuvigil tablets 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths," it added in a statement.

As per the IMS Health data, Nuvigil tablets in the five strengths had sales of nearly USD 420 million for the twelve months ending March, 2013 in the American market, Lupin said.

The product is indicated to improve wakefulness in adult patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), narcolepsy, or shift work disorder, it added.

The company`s Doxycycline capsule is generic equivalent of Galderma Laboratories` Oracea capsules in the strength of 40 mg.
Oracea capsules had annual sales of nearly USD 319 million for the twelve months ending March, 2013 in the US as per the IMS Health data, Lupin said.

"Doxycycline capsule is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients," it added.

Shares of Lupin Ltd were today trading at Rs 875 per scrip in the afternoon trade on BSE, up 4.17 per cent from their previous close.

PTI

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